Regulatory Manager​/Senior Regulatory Manager; Clinical Trials

Regulatory Manager / Senior Regulatory Manager (Clinical Trials)

Precision for Medicine is a leading CRO focused on oncology and rare disease. We integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to accelerate the delivery of life‑changing therapies.

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager (depending on experience) to join our team. The role provides regulatory strategy and development guidance for optimal conduct of clinical trials and regulatory agency meetings, orphan designations, paediatric planning and accelerated procedures. It ensures timely preparation of well‑organised, quality regulatory submissions in compliance with applicable regulations.

• Provide regulatory guidance throughout the clinical development life cycle.
• Compile, coordinate and review applications to regulatory authorities (CTA/IND, annual reports, routine amendments, scientific advice meetings, orphan designations, paediatric planning, marketing applications). Provide strategic regulatory input as required.
• Develop and/or review documents intended for submission to regulatory authorities and/or ethics committees to assure compliance with regulatory standards.
• Serve as the representative of Global Regulatory Affairs at project team meetings with external and internal customers.
• Work within a project team and, where necessary, lead projects for the region or globally.
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs.
• Maintain project plans, tracker and regulatory intelligence tools and keep regulatory leadership updated.
• Assist in development of Regulatory Affairs Specialists and other operational staff, as required.
• Provide input into regulatory strategy and timeline development for new study opportunities and help establish company standards for the highest quality of submitted information.
• Participate in maintaining and executing corporate quality initiatives across business units within clinical solutions.
• Keep abreast of and continually expand knowledge of laws, regulations and guidelines governing drug development and approval.
• Provide ICH GCP guidance, advice and training to internal and external clients.
• Represent Global Regulatory Affairs at business development meetings.

• Bachelor’s degree or equivalent experience, ideally in a scientific or healthcare discipline.
• 5 years regulatory experience required for the Manager level and 7 years required for the Senior Manager level.
• Computer literacy (MS Office/Office 365).
• Fluent in English.

• Graduate or postgraduate education.
• Basic understanding of financial management.

Candidates must have regulatory affairs experience working for a Clinical Research Organisation and experience leading clinical submissions. They must possess informed knowledge of all aspects of the drug development process, including regulatory milestones and specialized knowledge for at least one major region (EU, US). They should be able to understand clinical and pre‑clinical study results, interpret them for regulatory positions and strategy, and have knowledge of clinical trials methodology and regulations.

Availability for domestic and international travel, including overnight stays, is required.

• Strong interpersonal skills and proven ability to contribute to a team environment involving multifaceted research activities.
• Demonstrates professionalism, punctuality, commitment delivery, and positive interactions with customers and teammates.
• Can manage multiple tasks in a fast‑moving environment, with good record‑keeping skills.
• Self‑motivated and able to work independently as well as in a team.
• Motivates other project team members to meet timelines and project goals.
• Adopts a flexible attitude toward work assignments and new learning.
• Resolves project‑related problems and prioritises workload to meet deadlines with little management support.
• Focuses on continuous improvement, proactively assessing ways to make processes more efficient.
• Collects consistently…